BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 6182831 · Received December 16, 2016

    Report

    Report Number
    3008772169-2016-00845
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    December 6, 2016
    Report Date
    March 30, 2017
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION PROVIDED IN AGE/DATE OF BIRTH. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED AN ANTERIOR CAPSULE TEAR WAS NOTED ON A PATIENT'S RIGHT EYE DURING INSERTION AND ASPIRATION PORTION OF A LASER ASSISTED CATARACT PROCEDURE. A SMALL BUBBLE WAS NOTED AROUND 9 O'CLOCK AT THE CAPSULE EDGE. THE DOCTOR INCREASED THE LASER ENERGY TO ENSURE A FREE CAPSULE. CAPSULE WAS FREE AND REMOVED WITHOUT DIFFICULTY. THE TEAR WAS NOTED IN THE AREA WHERE THE BUBBLE HAD BEEN. THE PLANNED INTRAOCULAR LENS WAS PLACED IN THE BAG. THE DOCTOR IS UNSURE HOW THE EVENT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832184 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other